It is a mesh like medical device that is constructed out of plastic or biological material, most commonly a plastic coated with biological materials. Transvaginal mesh is implanted through the vagina or “transvaginally” and not through a more traditional abdominal surgery. Transvaginal mesh was intended to be an improvement on previous procedures such as retropubic urethroplexy, pelvic reconstruction, or colpocleisis.

Though it was intended to be safer and more effective than other procedures, it has proven to cause a number of adverse events, some of which are permanently debilitating or may be life-threatening.
Transvaginal Mesh Global Roundup: Sensational, Scandal and Settlement. British tabloids have sensationalised transvaginal mesh by describing one victim’s botched surgery a “biting vagina”; an Australian Senator compares the mesh to Thalidomide as one of Australia's worst health scandals; and in the US a transvaginal mesh class action lawsuit is settled for $12.3 million.

Sensationalized in the UK: The Biting Vagina The “Biting Vagina” story first told by Theresa Bartram on her Facebook page has been sensationalized by the Daily Mail, reporting that she “was left with a Venus flytrap vagina that 'bit' her partner during sex after surgery for incontinence that went horribly wrong.” Bartram’s TVT led to serious problems including ‘ripping a chunk’ from her partner’s penis. Trust a British tabloid to pen this: “It was like [my vagina] had grown teeth,' she recalled.
IN RE ETHICON, INC., PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION. Transvaginal Mesh Deaths Reported as Injuries?
“A good number of attorneys have reported transvaginal mesh adverse events to the FDA on behalf of their clients/patients, but over 23,000 reports are from physicians,” says Madris Tomes, founder of Device Events and former FDA Program Manager.

“Physicians are not great at reporting— this is a HUGE number.” During her tenure at the FDA, Tomes worked on the agency’s adverse event reporting program. She can search the entire FDA medical device adverse events data since 1996. For instance, Tomes recently investigated Essure complaints and found 303 reports referencing these fetal “death like” terms—reported as injuries rather than deaths-- and provided the information to Congressman Mike Fitzpatrick with the goal to remove Essure from the market.

Even More Warnings for Transvaginal Mesh - Dangerous Medicines. Boston Scientific Corporation announced this summer that it is once again adding new warnings to the labels for its surgical mesh devices.

According to the Minneapolis Star Tribune, the products will now warn of “ongoing pain.” The labels will also finally disclose that mesh devices are permanent implants, that removal may be complicated or impossible, and that treatment for post-implant complications may require surgical removal of the device. The changes to the device labels affect five Boston Scientific brands of transvaginal mesh slings (Advantage, Lynx, Obtryx, Obtryx II, and Solyx) and three types of pelvic organ prolapse kits (Uphold LITE, Pinnacle LITE, and Upsylon Y). The changes were announced in an “urgent” advisory letters sent to doctors worldwide, according to the report.
Transvaginal Mesh Complications May Take Risky Product Off Market. The FDA has recently issued a press release announcing that the makers of surgical mesh products used to treat pelvic organ prolapse (POP) must reclassify the devices as Class III, or high risk medical devices.

Because of transvaginal mesh complications, manufacturers will also have to receive premarket approval (PMA) to continue selling the product. Dr. William Maisel, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, said “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.” What is Pelvic Organ Prolapse? It is a serious problem that causes pelvic pain, urinary issues and complications with intercourse.
Pelvic Mesh Likely to See Piecemeal, Not Global, Resolution. Transvaginal Mesh: Chilling Allegations in State Lawsuits Against Johnson & Johnson — North Carolina Product Liability Lawyer Blog. So maybe you’ve heard the news that Washington and California recently sued Johnson & Johnson for misrepresenting the safety of its transvaginal mesh (or “pelvic mesh”) products.

I pulled the Washington lawsuit and read it. It is alarming. If Washington can prove the allegations in the complaint, it will be a damning indictment of Johnson & Johnson and the pelvic mesh industry generally. The Washington Lawsuit States can sue companies on behalf of their injured citizens. Let’s look at some of the key allegations in the Washington State lawsuit.

The suits were part of a multidistrict litigation (MDL) in West Virginia. AMS, owned by Endo International PLC, faced litigation due to injuries caused by its vaginal mesh devices, including the Apogee and Perigee systems, as well as the MiniArc Sling and the IntePro Y Sling.
AGs: Pelvic mesh implants caused dire complications. According to California's attorney general, J&J sold more than 787,000 pelvic mesh devices in the United States from 2008 until 2014, including more than 42,000 in California.

The lawsuits, which were filed in California and Washington state, allege that Johnson & Johnson failed to disclose a host of problems caused by the devices, which are created to treat the conditions stress urinary incontinence and pelvic organ prolapse. The lawsuit alleges that Johnson & Johnson misrepresented the safety of the devices by concealing the possibility of serious and irreversible complications caused by mesh, including permanent pain with intercourse and/or loss of sexual function, chronic pain, permanent urinary or defecatory dysfunction, and a potentially devastating impact on overall quality of life.

The lawsuit accuses Johnson & Johnson of misrepresenting the risks of the pelvic mesh, noting that thousands of women in Washington state have faced medical complications.
Transvaginal Mesh Nerve Damage “Horrendous”
Imagine not knowing when you have to urinate.

It happened to all of us as babies, and it happens to some elders. But Yolanda is in her 40s and she has been living with this horrific incontinence since having transvaginal mesh implanted five years ago! Generally, urinary stress incontinence means leakage of urine when you cough, laugh, bend over or exercise. If only that was all Yolanda (not her real name) had to deal with. She had the mesh implanted when she had surgery to remove fibroids, non-cancerous tumors that develop in the uterus.
Vaginal Mesh Lawsuit Upheld by Appellate Court. At the end of April, the U.S.

Court of Appeals for the Fourth Circuit upheld the ruling by a lower court that a woman’s vaginal mesh lawsuit should be tossed out because it exceeded the statute of limitations. The appellate court concluded that plaintiff Brenda R.’s claims, along with her husband’s claims, came too long after the implantation of the product. The judges said Brenda, a Utah resident, should have begun questioning the mesh’s quality before the end of 2007. Utah has a statute of limitations of two years for any product liability claims to be filed. Brenda’s case was initially part of the MDL against Boston Scientific Corp., manufacturer of Brenda’s vaginal mesh.
To Webcast $6M+ Boston Scientific Pelvic Mesh Trial In Massachusetts. Woburn, MA — Opening statements begin Monday in a Massachusetts state courtroom in a potentially $6 million product liability lawsuit against Boston Scientific Corp. claiming one of the company’s allegedly defective pelvic mesh implants caused a woman to suffer chronic pain and to need numerous additional surgeries.

Plaintiff Ronda Orozco’s lawsuit accuses Boston Scientific of using a type of polyurethane mesh in its Uphold-brand implant that her attorneys argue is not suitable for use in humans. They claim the mesh reacts to human bodily fluids and becomes stiff and brittle, which supposedly left Orozco suffering from bleeding, incontinence and pain during sexual intercourse. She seeks up to $6 million in compensatory damages and an unspecified amount in punitive damages, according to court filings. The full trial will be webcast and recorded gavel-to-gavel by Courtroom View Network. That trial, like Orozco’s case, was also webcast and recorded gavel-to-gavel by CVN.

Why The Transvaginal Mesh Litigation Won't Become A "Black Hole" Like Asbestos. The transvaginal mesh litigation has for some time been the largest medical mass tort ever, at least as measured by filings in the federal multi-district litigation (MDL), which is currently being handled in the Southern District of West Virginia. There are over 42,000 cases in the MDL — more than the combined total of cases ever filed in the Prempro MDL (9,761), the Yasmin and Yaz MDL (11,423), the Vioxx MDL (10,319), and the DePuy ASR Hip Implant MDL (8,900).

(See this chart under “Total Actions.”) Add to that the over 6,000 mesh cases pending in New Jersey state court, and numerous cases filed in other state courts, and there are nearly 50,000 transvaginal mesh claims pending in courts across the country against six different manufacturers. So what are the courts supposed to do with that many cases? But when you’re talking about 50,000 medical device cases, that’s easier said than done.
Allergic to AMS Transvaginal Mesh. June says she has been suffering from a serious allergic reaction to AMS transvaginal mesh, which is made with polypropylene, since she had the mesh implanted in 2013. “I went back to the hospital - here in northern Ontario - and they just told me to take Benedryl for the itch,” says June. It is rare that transvaginal mesh for urinary incontinence or pelvic organ prolapse causes an allergic reaction, but Dr. Christopher Walker, an award-winning urogynecologist who specializes in revision surgeries involving transvaginal mesh, told DrugWatch (February 2013) that there are reports of patients being allergic to the polypropylene.

“Because they are allergic to it, they have an autoimmune response, inflammation and chronic pain. You have to take out all the pieces of mesh, which is a difficult thing to do.” June wasn’t able to find a doctor in Canada, and particularly not a urologist, to remove the mesh. Latex allergy can result in potentially serious health problems, as June attests.

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Urogynecology expert witness says manufacturer failed to disclose problems with transvaginal mesh. A urogynecology expert witness advises on a case involving female plaintiffs who underwent pelvic repair with mesh implants to relieve various urinary problems. They allege that the mesh, manufactured and marketed by the defendants, is defective and caused them debilitating pain and damage, requiring additional surgeries and ongoing treatment.

The plaintiffs assert that pelvic mesh products contain monofilament polypropylene mesh that, despite the defendants’ claims, is not inert. Scientific evidence shows that this material as implanted is biologically incompatible with human tissue and promotes a negative immune response in a large subset of the population that has been implanted with it. This negative response promotes inflammation of the pelvic tissue and can contribute to the formation of severe adverse reactions to the mesh.

Transvaginal Mesh—The Past Five Years. From 2011, the FDA has warned health professionals and the public that transvaginal mesh was associated with serious complications that were not rare, and recommended the mesh be bumped up from moderate to high risk. Almost five years later, the agency has reclassified mesh products designed and marketed for transvaginal treatment of POP to Class III “High Risk Devices,” which means more stringent regulatory requirements for the manufacturers.
BLADDER SLING ATTORNEYS.

Reckless: American attorney savages multinational healthcare manufacturer over faulty mesh implant used in Scotland. Johnson & Johnson loses another pelvic mesh suit. The Legal Intelligencer. When a Brain Surgeon Becomes a Malpractice Lawyer. The line drive ripped off the hitter’s bat and rocketed into the right hand of Dr. Lawrence Schlachter, shattering bones and ending his career as a neurosurgeon.
Verdicts in Philadelphia Pelvic Mesh Cases Troubling for Johnson & Johnson - NewsInfernoNewsInferno. After two jury verdicts, each exceeding $12 million, in the first pelvic mesh cases to go to trial, legal experts say Johnson & Johnson should seriously consider settling the roughly 150 cases remaining in the mass tort program and focusing on the much larger federal multidistrict litigation.

On February 10, 2016, the jury returned a $13.5 million verdict against J&J’s Ethicon unit, maker of the Prolift pelvic mesh implant. The verdict included $10 million in punitive damages. In December, the company was hit with a $12.5 million jury verdict that included $7 million in punitive damages, Law360 reports.
AMS Transvaginal Mesh Settlement Money “Chump Change”
Andrea recently received a transvaginal mesh settlement offer from American Medical Systems (AMS), but she says it’s little more than “chump change” given the four-year nightmare she has gone through since the device was implanted, and it ain’t over yet... For most women who have suffered adverse events from the mesh and filed a lawsuit against AMS, the company is offering $40,000. Women who’ve been more seriously injured are receiving settlements of $250,000 or more, depending upon which “tier” you fit into (your attorney can assist you).